Orifice introducer device

ABSTRACT

An orifice introducer device for introducing, e.g., a surgical device, into, e.g., an orifice of a body, includes a tubular member having a distal end and a proximal end. The distal end is adjustable between a first position for insertion into an orifice and a second position once inserted into the orifice. Alternatively, the orifice introducer device includes a distal portion having a proximal end configured to be detachably secured to the distal end of the tubular member. The distal portion is selectively detachable when the orifice introducer device is positioned in the orifice.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit under 35 U.S.C. §119(e) ofU.S. Provisional Patent Application No. 60/400,023, filed on Jul. 31,2002, which is expressly incorporated herein by reference in itsentirety.

FIELD OF THE INVENTION

[0002] The present invention relates to an orifice introducer device,and more particularly, to an orifice introducer device for introducing,e.g., a surgical device, into an orifice of a body.

BACKGROUND

[0003] There are many surgical procedures that require a surgicalinstrument to be introduced into an orifice of a body. One example ofsuch is a surgical procedure to resect a cancerous or anomalous tissuefrom a gastro-intestinal tract by the introduction, e.g., insertion, ofa circular stapling instrument via a patient's oral or anal cavity.

[0004] One of the problems experienced during surgical procedures ofthis type is that the orifice of the body may be damaged when thesurgical instrument is being introduced, or has been introduced, intothe orifice. This is particularly problematic when the orifice intowhich the surgical device is being introduced includes fragile tissuethat is easily damaged when contacted, e.g., the tissues of the oralcavity. Another problem experienced during surgical procedures of thistype is that the surgical instrument may be damaged when the surgicalinstrument is being introduced, or has been introduced, into theorifice. It may be particularly important to avoid damage to thesurgical device, since a patient may also be harmed if the surgicaldevice functions improperly.

[0005] While significant advances have been made in miniaturizingsurgical instruments, there are still many surgical instruments that arealmost as large as, the same size as, or larger than, the size of theorifice into which the surgical instrument is required to be introduced.Since the likelihood of damaging either the orifice or the surgicaldevice may be increased as the size of the surgical device increasesrelative to the size of the orifice into which the surgical instrumentis required to be introduced, conventional surgical devices andprocedures still risk damage to one or both of the surgical device andthe orifice.

[0006] Thus, there is a need for a device that minimizes the likelihoodof damage to one or both of a surgical device and an orifice when thesurgical device is introduced into the orifice.

SUMMARY

[0007] The present invention, according to various embodiments thereof,relates to an orifice introducer device for introducing, e.g., asurgical device, into, e.g., an orifice of a body. The orificeintroducer device includes a tubular member having a distal end and aproximal end. The distal end is adjustable between a first position forinsertion into an orifice and a second position once inserted into theorifice. Alternatively, the orifice introducer device may include adistal portion having a proximal end configured to be detachably securedto the distal end of the tubular member. The distal portion isselectively detachable when the orifice introducer device is positionedin the orifice.

[0008] In another example embodiment of the present invention, theintroducer includes a tubular sheath. The diameter of the proximal endof the sheath is larger than the diameter of the distal end of thesheath. For example, the sheath may have a generally conically-shaped ortapered distal end. The diameter of the distal end may be expandable toallow passage of a surgical instrument whose diameter is larger than thediameter of the distal end. The distal end may include, for example, aslit, seam or weakened area for allowing the diameter to expand.Alternatively or additionally, the distal end may be formed of astretchable material, such as an elastomeric material, which allows thediameter of the proximal end to expand.

[0009] In another example embodiment of the present invention, theintroducer includes a sheath and a distal cap-like portion (e.g., a nosecone). The distal cap-like portion may be removably mounted to thesheath. The cap-like portion may be removed from the sheath andwithdrawn or recovered through the sheath.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010]FIG. 1A is a side view that illustrates an orifice introducerdevice in a closed position, according to one example embodiment of thepresent invention;

[0011]FIG. 1B is a side view that illustrates, in an open position, theorifice introducer device illustrated in FIG. 1A;

[0012]FIG. 2A is a perspective view that illustrates an orificeintroducer device according to another example embodiment of the presentinvention.

[0013]FIG. 2B is a partial perspective view that illustrates furtherdetails of a proximal end of the orifice introducer device illustratedin FIG. 2A;

[0014]FIG. 2C is a partial side view that illustrates further details ofa distal end of the orifice introducer device illustrated in FIG. 2A ina closed position;

[0015]FIG. 2D is a side view that illustrates further details of thedistal end of the orifice introducer device illustrated in FIG. 2A in anopen position;

[0016]FIG. 3A is a side view that illustrates an orifice introducerdevice according to another example embodiment of the present invention;

[0017]FIG. 3B is a partial, cross-sectional side view of the orificeintroducer device illustrated in FIG. 3A;

[0018]FIG. 3C is a partial, cross-sectional side view that illustratesfurther details of an attached distal portion of the orifice introducerdevice illustrated in FIG. 3A;

[0019]FIG. 3D is a partial, cross-sectional side view that illustratesfurther details of a detached distal portion of the orifice introducerdevice illustrated in FIG. 3A;

[0020]FIG. 3E is a partial, cross-sectional side view of the orificeintroducer device illustrated in FIG. 3A having a second tubular bodyinserted therein;

[0021]FIG. 3F is a partial, cross-sectional side view of the orificeintroducer device illustrated in FIG. 3A having the second tubular bodyfurther inserted therein; and

[0022]FIG. 3G is a partial, cross-sectional side view of the orificeintroducer device illustrated in FIG. 3A having distal portion partiallywithdrawn therethrough.

DETAILED DESCRIPTION

[0023] The present invention, according to various embodiments thereof,relates to an orifice introducer device that may be used, for example,for introducing or inserting, e.g., a surgical device, into an orifice,e.g., an oral cavity, of a body. For the purposes of example only, thepresent invention will be described hereinafter in connection with anorifice introducer device that is used for introducing or inserting asurgical device into an orifice of a body. However, it should berecognized that the present invention, in accordance with otherembodiments thereof, may also be used for introducing or insertinganything, e.g., a surgeon's hand, an implantable medical device, etc.,into an orifice of a body. Additionally or alternatively, it should berecognized that the present invention, in accordance with otherembodiments thereof, may also be used for widening or otherwise changingthe shape of an orifice of a body for purposes other than introducing orinserting something into the orifice of a body, e.g., for enabling asurgeon to view externally the interior of the orifice withoutintroducing or inserting anything therein. Still further, it should berecognized that the present invention, in accordance with otherembodiments thereof, may also be used for introducing or inserting anelement into any type of orifice, not merely an orifice of a body.

[0024] Advantageously, the orifice introducer device of the presentinvention may function to prevent damage to either the orifice of thebody or to the surgical instrument when the surgical instrument is beingintroduced or inserted, or has been introduced or inserted, into theorifice. Additionally or alternatively, the orifice introducer devicemay function so that a surgical instrument having a relatively largediameter may pass through an orifice having a relatively smallerdiameter without damaging the orifice. Preferably, the orificeintroducer device has a first position or arrangement in which theorifice introducer device is configured to be easily inserted into anorifice. In addition, the orifice introducer device is adjustable to asecond position or arrangement in which the orifice introducer devicemay accommodate, e.g., a larger surgical instrument therethrough, by,for example, maintaining, stretching or otherwise changing the shape of,an orifice so that the larger surgical device may be inserted andpositioned therein. Preferably, the orifice introducer device isconfigured to be sterilizable, enabling it to be used more than once.

[0025]FIGS. 1A and 1B illustrate, in a first position and a secondposition, respectively, an orifice introducer device 100 suitable forintroducing a surgical device into an orifice of a body, in accordancewith an example embodiment of the present invention. In this embodiment,the orifice introducer device 100 includes a generally tubular member 1.The tubular member 1 has a proximal end 1 a and a distal end 1 b. Adiameter of the distal end 1 b is, in the first position, smaller thanthe diameter of the proximal end 1 a. In this embodiment, the distal end1 b is generally conical or tapered in the first position. In addition,the distal end 1 b includes, in the embodiment shown, a longitudinalslit 2.

[0026]FIG. 1B illustrates the adjustability of the distal end 1 b. Morespecifically, FIG. 1B illustrates that, in the second position, thedistal end 1 b is adjusted such that an diameter of the distal end 1 bis increased, e.g., expanded, relative to the diameter of the distal end1 b in the first position. For instance, the inner diameter of thedistal end 1 b is expanded to allow a surgical device, for example asurgical device having a diameter that is larger than the diameter ofthe distal end 1 b in the first position, to pass therethrough. In thisembodiment, the distal end 1 b is adjustable by the opening of thelongitudinal slit 2.

[0027] In operation, the distal end 1 b of the tubular member 1 isintroduced into an orifice and is advanced in a distal direction untilit achieves a desired position within the orifice. The relativelysmaller diameter at the distal end 1 b permits the orifice introducerdevice 100 to be more easily introduced and advanced into the orifice.Preferably, when the orifice introducer device 100 is positioned in thedesired position, the proximal end 1 a of the tubular member 1 remainsoutside of the orifice. A surgical instrument, which may besterilizable, may then be inserted into the tubular member 1 and may beadvanced distally therethrough. The surgical instrument may include, forexample, a surgical instrument attached to a flexible shaft of anelectromechanical driver, as described in, for example, U.S. Pat. No.6,443,973, entitled “Electromechanical Driver Device For Use WithAnastomosing, Stapling, and Resecting Instruments,” filed on Jun. 2,1999, U.S. patent application Ser. No. 09/510,927, entitled “AnElectromechanical Driver And Remote Surgical Instruments AttachmentsHaving Computer Assisted Control Capabilities, filed on Feb. 22, 2000,U.S. Pat. No. 6,517,565 entitled “Carriage Assembly for Controlling aSteering Wire Steering Mechanism Within a Flexible Shaft”, filed on Feb.22, 2000, U.S. Pat. No. 6,315,184, entitled “Stapling Device For UseWith An Electromechanical Driver Device For User With Anastomosing,Stapling, And Resecting Instruments,” U.S. Pat. No. 6,264,087, entitled“Parallel Jaw Device For Use With An Electromechanical Driver Device,”U.S. Pat. No. 6,348,061, entitled “Vessel And Lumen Expander AttachmentFor Use With An Electromechanical Driver Device,” U.S. Pat. No.6,488,197, entitled “Fluid Delivery Device For Use With Anastomosing,Resecting and Stapling Instruments, filed on Feb. 22, 2000, U.S. Pat.No. 6,491,201, entitled “A Fluid Delivery Mechanism For Use WithAnastomosing, Resecting And Stapling Instruments, filed on Feb. 22,2000, U.S. Pat. No. 6,533,157, entitled “A Tissue Stapling AttachmentFor Use With An Electromechanical Driver Device, filed on Feb. 22, 2000,U.S. patent application Ser. No. 09/887,789, entitled“Electro-Mechanical Surgical Device,” filed on Jun. 22, 2001, U.S.patent application Ser. No. 10/098,217, entitled “Trocar Device,” filedon Mar. 14, 2002, U.S. patent application Ser. No. 10/128,768, entitled“Bipolar Or Ultrasonic Surgical Device, filed on Apr. 22, 2002, U.S.patent application Ser. No. 10/127,310, entitled “Imaging Device,” filedon Apr. 22, 2002, U.S. Patent Application Ser. No. 60/352,726, entitled“Surgical Imaging Device,” filed on Jan. 30, 2002, U.S. patentapplication Ser. No. 09/999,546, entitled “Surgical Device,” filed onNov. 30, 2001, U.S. patent application Ser. No. 10/094,051, entitled “ASurgical Device,” filed on Mar. 8, 2002, and U.S. Patent ApplicationSer. No. 60/388,644, entitled “Surgical Device,” filed on Jun. 14, 2002,each of which is expressly incorporated by reference in its entirety.

[0028] When the surgical instrument reaches the distal end 1 b of thetubular member 1, the diameter of the distal end 1 b may be adjusted,e.g., expanded, so as to permit at least a portion of the surgicalinstrument to enter, e.g., to extend through, the distal end 1 b. Theexpansion of the distal end 1 b may be caused by, for example, the forceof the surgical instrument pushing against the inner wall of the tubularmember 1. In the example shown in FIGS. 1A and 1B, the distal end 1 bexpands via the longitudinal slit 2, e.g., by the separation of thesides 2 a and 2 b of the slit 2, to allow the surgical instrument topass therethrough.

[0029] While the embodiment of FIGS. 1A to 1B illustrates that thedistal end 1 b of the tubular member 1 may be adjustable, e.g.,expandable, alternative arrangements are possible in which the entiretubular member 1 is adjustable. Furthermore, while the embodiment ofFIGS. 1A to 1B illustrates that the distal end 1 b of the tubular member1 may be adjustable, e.g., expandable, via a slit 2, alternativearrangements for providing adjustability to the distal end 1 b are alsopossible. For example, the distal end 1 b of the tubular member 1 may beformed of a stretchable material, such as an elastomeric material,whereby the force of the surgical instrument, e.g., a surgicalinstrument having a diameter that is larger than the diameter of thedistal end 1 b in a first position, against the inner wall of thetubular member 1 may stretch the material of the distal end 1 b to allowthe diameter of the distal end 1 b to increase and the surgicalinstrument to pass therethrough. Alternatively or additionally, thedistal end 1 b of the tubular member 1 may include one or more seams,perforations, or weakened areas that tear, split or otherwise open orstretch to allow the inner diameter of the distal end 1 b of the tubularmember 1 to increase.

[0030]FIGS. 2A to 2D illustrate an orifice introducer device 200 inaccordance with another example embodiment of the present invention. Inthis embodiment, and as illustrated in FIG. 2A, the orifice introducerdevice 200 includes a tubular member 21 having a proximal end 21 a and adistal end 21 b. The distal end 21 b of the tubular member 21 includes alongitudinally extending v-shaped opening or slit 21 e, with a distalend of the opening 21 e being wider in the open position than a proximalend of the opening 21 e. In this embodiment, each of the sides 21 c, 21d of the opening 21 e includes a number of holes 22 through which astring 22 a may be laced, threaded or corsetted. The proximal end 21 aof the tubular member 21 includes an actuation device 20. The actuationdevice 20 may include a ring 25 or the like for gripping the string 22a.

[0031] As shown in further detail in FIG. 2B, the ring 25 may include ahole 25 a through which both ends of the string 22 a pass. Specifically,the first and second ends of the string 22 a are laced within the holes22 at the distal end 21 b of the orifice introducer device 100, extendthrough the interior of the tubular member 21 and emerge through holes23 and 27 a, respectively. The first and second ends of the string 22 aare secured to the ring 25 through the hole 25 a by a crimp 26. Asshown, the hole 27 a may include a grommet 27 to, for example, reducethe friction of the string 22 a against the sides of the hole 27 a.

[0032] Prior to insertion of the orifice introducer device 200 into anorifice, the ring 25 may be moved, e.g., pulled in a proximal direction,to draw the sides 21 c and 21 d of the opening 21 e together and therebyreduce the diameter of the distal end 21 b of the tubular member 21 asillustrated in FIG. 2C. The reduced diameter of the distal end 21 b ofthe tubular member 21 permits easier insertion of the orifice introducerdevice 200 into an orifice. After the orifice introducer device 200 hasbeen inserted into an orifice and is in a desired position, the diameterof the distal end 21 b of the tubular member 21 may be increased asillustrated in FIG. 2D to allow a surgical instrument to be passedtherethrough. In order to increase the diameter of the distal end 21 bof the tubular member 21, the ring 25 may be moved in an oppositedirection, e.g., in a distal direction, thereby releasing the tension onstring 22 a.

[0033] It should be recognized that there are numerous differentarrangements that may be employed for lacing the string 22 a through theholes 22 at the distal end 21 b of the tubular member 21 and forsecuring the string 22 a to an actuation device 20, such as the ring 25,at the proximal end 21 a of the tubular member 21. For instance, inanother example embodiment of the present invention, the crimp 26 may besecured to the tubular member 21 at a proximal side of the hole 27 a.The first and second ends of the string 22 a may extend through the hole25 a of the ring 25 to be connected to the crimp 26. The ring 25 maythen be moved in one direction, e.g., distally, to decrease the diameterof the distal end 21 b of the tubular member 21 and in an oppositedirection, e.g., proximally, to increase the diameter of the distal end21 b of the tubular member 21.

[0034]FIGS. 3A to 3G illustrate an orifice introducer device 400, andthe use thereof, according to another example embodiment of the presentinvention. In this embodiment, a generally tubular member 300 isprovided with a distal portion 310, e.g., a nose cone, at a distal end315 thereof. The tubular member 300 may be formed from, for example, aTeflon material. The distal portion 310 is configured to be detachablymounted to the distal end 315 of the tubular member 300. The distalportion 310 may be generally conically shaped or tapered so that adistal end of distal portion 310 has a smaller diameter than a proximalend of the distal portion 310 and the tubular member 300. The distalportion 310 is generally sized and shaped to be inserted into anorifice. The distal portion 310 may have an open or closed distal end,and may be, for example, tapered, conical, frusto-conical, blunt, etc.,in shape. The proximal end 325 of the distal portion 310 may begenerally annularly shaped so as to be attachable to the distal end 315of the tubular member 300. In this embodiment, the distal portion 310may be at least partially formed from a flexible, e.g., elastomeric,material. The distal portion 310 may be, for example, stretched aroundthe distal end 315 of the tubular member 300. Additionally oralternatively, other methods and/or devices can be used to attach thedistal portion 310 to the distal end 315 of the tubular member 300,including by way of non-limiting example: an electrical connection, anadhesive, a tacky composition, a coupling member, a fastener, a materialwhich molecularly binds with the material of the tubular member, etc.

[0035]FIG. 3B is a partial cross-sectional view of the orificeintroducer device 400 illustrated in FIG. 3A. As shown in FIG. 3B, theproximal end 325 of the distal portion 310 includes an annular groove320. The annular groove 320 is configured to receive the distal end 315of the tubular member 300. FIG. 3C shows further details of a portion ofthe annular groove 320. As shown in FIG. 3C, the annular groove 320 isconfigured to frictionally retain between opposing members 320 a and 320b the distal end 315 of the tubular member 300.

[0036] As noted above, in this embodiment, the distal portion 310 may beformed from a flexible, e.g., elastomeric, material. FIG. 3D illustratesthe portion of the annular groove 320 shown in FIG. 3C, when the distalend 315 of the tubular member 300 is not inserted therein. As shown inFIG. 3D, the proximal end 325 of the distal portion 310 in which theannular groove 320 is housed is biased so as to bend inwardly, e.g., tohave a reduced diameter, when the distal end 315 of the tubular member300 is not inserted in the annular groove 320. Preferably, the proximalend 325 of the distal portion 310 is sufficiently biased such that, whenthe distal end 315 of the tubular member 300 is not inserted in theannular groove 320, the inwardly-bent proximal end 325 of the distalportion 310 has an outer diameter that is less than an inner diameter ofthe tubular member 300.

[0037]FIGS. 3E to 3G illustrate the use of the orifice introducer device300 shown in FIGS. 3A to 3D, according to one example embodiment of thepresent invention. In this embodiment, the orifice introducer device 400is used with a tubular insertion device 330. For instance, FIG. 3Eillustrates the orifice introducer device 400 having a tubular insertiondevice 330 inserted therethrough. In one embodiment, the tubularinsertion device 330 is formed from a Teflon material. The tubularinsertion device 330 is slidably receivable in the tubular member 300and is configured to contact an inner wall 311 of the distal portion310. Preferably, the tubular insertion device 330 has a sufficientlength such that, when fully inserted through the tubular member 300, aproximal end 330 a of the tubular insertion device 330 extends beyond aproximal end 300 a of the tubular member 300 permitting manipulation ofthe tubular insertion device 330 by a surgeon outside the orifice.

[0038] The orifice introducer device of FIG. 3E further includes arecovery device such as a string 340 securely attached to the inner wall311 of the distal portion 310. Preferably, a proximal end 340 a of thestring 340 extends beyond the proximal end of the tubular member 300 sothat the string 340 can be held and/or pulled by a surgeon in a proximaldirection while the tubular member 300 is left in position within theorifice.

[0039] In operation, the distal portion 310 is detachably mounted on thetubular member 300 via, e.g., the annular groove 320. The tubular member300, including the distal portion 310 is then introduced into theorifice. Once the tubular member 300 is properly position, the tubularinsertion device 330 is inserted into the tubular member 300.Alternatively, the tubular insertion device 330 may be inserted into thetubular member 300 prior to introduction and/or positioning of thetubular member 300 in the orifice. The tubular insertion device 330 isthen advanced within the tubular member 300 in a distal direction, untilthe distal end of the tubular insertion device 330 contacts the innerwall 311 of the distal portion 310. The tubular insertion device 330 isthen further distally advanced so as to cause the distal portion 310 tobe detached from the proximal end 300 a of the tubular member 300.Alternatively, the tubular member 300 may be pulled back proximally,while the tubular insertion device 330 is kept in place. FIG. 3F shows,for example, the distal portion 310 after it is detached from thetubular member 300.

[0040] Once the distal portion 310 is detached from the distal end 315of the tubular member 300, the proximal end 310 a of the distal portion310 may contract. Advantageously, the proximal end 310 a of the distalportion 310 contracts sufficiently such that the outer diameter of thedistal portion 310 is smaller than the inside diameter of the tubularmember 300. The tubular insertion device 330 then may be removed fromthe tubular member 300 by moving it proximally relative to the tubularmember 300. Moreover, since upon contraction the outer diameter of thedistal portion 310 is smaller than the inside diameter of the tubularmember, the distal portion 310 may be withdrawn through the tubularmember 300 by pulling the string 340 proximally. Thereafter, the tubularmember 300 remains in position within the orifice, and a surgical devicemay be inserted into the proximal end of the tubular member 300 andadvanced distally therethrough.

[0041] Alternatively, in one example embodiment of the presentinvention, the proximal end 310 a of the distal portion 310 contractssufficiently such that the outer diameter of the distal portion 310 issmaller than the inside diameter of the tubular insertion device 330,such that the distal portion 310 may be proximally withdrawn through thetubular insertion device 330 while leaving the tubular insertion device330 in place within the tubular member 300. In this embodiment, both thetubular member 300 and the tubular insertion device 330 may remain inposition within the orifice, and a surgical device may thereafter beinserted into the proximal end 330 a of the tubular insertion device 330and advanced distally therethrough.

[0042] Several embodiments of the present invention are specificallyillustrated and/or described herein. However, it will be appreciatedthat modifications and variations of the present invention are coveredby the above teachings without departing from the spirit and intendedscope of the present invention.

What is claimed is:
 1. An orifice introducer device comprising: atubular member having a distal end and a proximal end; the distal endbeing adjustable between a first position for insertion into an orificeand a second position once inserted into the orifice.
 2. The orificeintroducer device of claim 1, wherein, in the first position, the distalend has a smaller diameter than the proximal end.
 3. The orificeintroducer device of claim 2, wherein the diameter of the distal end isgreater in the second position relative to the first position.
 4. Theorifice introducer device of claim 3, wherein at least a portion of thedistal end is stretchable, and wherein the diameter of the distal end isadjusted to the second position relative to the first position bystretching.
 5. The orifice introducer device of claim 3, wherein thedistal end includes a slit, and wherein the diameter of the distal endis adjusted to the second position relative to the first position byopening of the slit.
 6. The orifice introducer device of claim 5,wherein the distal end includes a plurality of holes adjacent to theslit and a string through the holes, and wherein the opening of the slitis controlled by moving the string.
 7. The orifice introducer device ofclaim 6, wherein the string is attached to an actuation device forcontrolling a movement of the string.
 8. The orifice introducer deviceof claim 6, wherein one end of the string is attached to an actuationdevice.
 9. The orifice introducer device of claim 6, wherein both endsof the string are attached to an actuation device.
 10. The orificeintroducer device of claim 7, wherein the actuation device includes aring.
 11. An orifice introducer device comprising: a tubular memberhaving a distal end; a distal portion having a proximal end configuredto be detachably secured to the distal end of the tubular member, thedistal portion being selectively detachable when the orifice introducerdevice is positioned in the orifice.
 12. The orifice introducer deviceof claim 11, wherein, when secured to the distal end of the tubularmember, a distal end of the distal portion has a smaller diameter thanthe tubular member.
 13. The orifice introducer device of claim 12,wherein, when detached from the distal end of the tubular member, theproximal end of the distal portion contracts so as to have a smallerdiameter than the tubular member.
 14. The orifice introducer device ofclaim 13, wherein the proximal end of the distal portion includes anannular groove configured to detachably secure the distal end of thetubular member.
 15. The orifice introducer device of claim 11, furthercomprising a tubular insertion device configured to be insertablethrough the tubular member.
 16. The orifice introducer device of claim15, wherein the tubular insertion device is configured to detach thedistal portion from the tubular member when inserted through the tubularmember.
 17. The orifice introducer device of claim 16, furthercomprising a recovery device for withdrawing the distal portion throughthe tubular member when the distal portion has been detached from thetubular member.
 18. The orifice introducer device of claim 17, whereinthe recovery device is a string attached to an inner wall of the distalportion.
 19. The orifice introducer device of claim 16, wherein, whendetached from the distal end of the tubular member, the proximal end ofthe distal portion contracts so as to have a smaller diameter than thetubular insertion device so as to be withdrawn through the tubularinsertion device.
 20. The orifice introducer device of claim 11, whereinthe orifice introducer device is configured to introduce a surgicaldevice into an orifice.
 21. A method for using an orifice introducerdevice comprising the steps of: providing a tubular member having adistal end and a proximal end, the distal end being in a first positionin which the distal end has a smaller diameter than the proximal end;inserting the distal end into an orifice; and adjusting the distal endinto a second position.
 22. The method of claim 21, further comprisingthe step of inserting an element through the tubular member.
 23. Themethod of claim 22, wherein the inserting step includes inserting asurgical device through the tubular member.
 24. The method of claim 21,wherein the adjusting step includes adjusting the diameter of the distalend so as to be greater in the second position relative to the firstposition.
 25. The method of claim 21, wherein the adjusting stepincludes stretching at least a portion of the distal end.
 26. The methodof claim 21, wherein the adjusting step includes opening a slit in thedistal end.
 27. The method of claim 26, wherein the opening of the slitincludes the step of moving, via an actuation device, a string attachedto the slit.
 28. A method for using an orifice introducer devicecomprising the steps of: providing a tubular member having a distal end;detachably securing a proximal end of a distal portion to the distal endof the tubular member, a distal end of the distal portion having asmaller diameter than the tubular member; inserting the distal end intoan orifice; and selectively detaching the distal portion from thetubular member.
 29. The method of claim 28, further comprising the stepof the distal portion contracting so as to have a diameter smaller thana diameter of the tubular member.
 30. The method of claim 29, furthercomprising the step of withdrawing the distal portion through thetubular member.
 31. The method of claim 30, further comprising the stepof inserting an element through the tubular member.
 32. The method ofclaim 31, wherein the inserting step includes inserting a surgicaldevice through the tubular member.
 33. The method of claim 28, whereinthe selective detaching step includes inserting a tubular insertiondevice through the tubular member for contacting an inner wall of thedistal portion.
 34. An orifice introducer, comprising: a tubular sheathhaving a proximal end and a distal end, a diameter of the distal end ofthe sheath being expandable from a first diameter to a second diameterto allow passage of a surgical instrument having a diameter that islarger than the first diameter.
 35. The orifice introducer of claim 34,wherein the distal end of the sheath is conically shaped at least whenthe diameter of the sheath is the first diameter.
 36. The orificeintroducer of claim 34, wherein the distal end of the sheath is taperedat least when the diameter of the sheath is the first diameter.
 37. Theorifice introducer of claim 34, wherein the distal end of the sheathincludes at least one of a slit, a seam, a perforation and a weakenedarea, which allows the expansion of the distal end.
 38. The orificeintroducer of claim 34, wherein the distal end of the sheath is formedof a stretchable material so that the distal end of the sheath stretchesto expand from the first diameter to the second diameter.